(29 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves," dated August 14, 2003.
This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to a legally marketed predicate device. It certifies that the device can proceed to market under general controls.
The letter does not contain:
- Specific acceptance criteria (such as performance metrics like tensile strength, elongation, or barrier integrity). While such criteria would have been part of the manufacturer's submission, they are not detailed in this clearance letter.
- Details of the study or tests performed by Symertex Company Limited to demonstrate compliance with performance standards. The FDA's review in a 510(k) typically relies on the manufacturer's data demonstrating that their device meets recognized standards or is substantially equivalent to a predicate.
- Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies. These are typically associated with more complex medical devices that involve diagnostic or therapeutic algorithms, not examination gloves.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement clearly indicates the basis for clearance is substantial equivalence to a predicate, not necessarily detailed performance study results within this letter itself.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling an emblem. The emblem is a stylized design of what appears to be a human figure in profile, with three flowing lines emanating from the head, possibly representing growth or services provided by the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2003
Symertex Company Limited C/O Mr. Albert Ling 1404 Greenport Avenue Rowland Heights, California 91748
Re: K032172
Trade/Device Name: Disposable Powder Free Vinyl Exam Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 11, 2003 Received: July 16, 2003
Dear Mr. Ling:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ling
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | SYNMERTEX CO. LTD. |
|---|---|
| ------------ | -------------------- |
K032172 510(k) Number (if known):
DISPOSABLE POWDER FREE VINYL EXAM Device Name: GLOVES
Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qlin S. hom
Division Sign-Off) ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032172
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.